ms_07360070190V2.
PreciControl Lung Cancer
07360070 190 4 x 3.0mL
English
Intended use
PreciControl Lung Cancer is used for quality control of the Elecsys SCC,
ProGRP, CYFRA 211 and NSE immunoassays on the Elecsys and
cobase immunoassay analyzers.
Summary
PreciControl Lung Cancer is a lyophilized control based on human serum in
two concentration ranges. The controls are used for monitoring the
accuracy and precision of the specified Elecsys immunoassays.
Reagents - working solutions
PC LC 1: 2bottles, each for 3.0mL of control serum
PC LC 2: 2bottles, each for 3.0mL of control serum
The exact lotspecific target values and ranges are encoded in the
barcodes as well as printed on the enclosed (or electronically available)
value sheet.
Target values and ranges
The target values and ranges were determined and evaluated by Roche.
They were obtained using the specified Elecsys assay reagents and
analyzers available at the time of testing.
If the target values and control ranges are updated, this information is
conveyed either via the reagent barcodes, or control barcodes (or provided
electronically) and in an additional value sheet included in the reagent kit.
This value sheet lists all control lots to which the new values apply. If some
of the values remain unchanged, the original values conveyed via the CBC
(Control Barcode), and in the value sheet included in the control kit (or
provided electronically), remain valid.
Results must be within the specified ranges. In the event that increasing or
decreasing trends, or any other suddenly occurring deviations beyond the
range limits are observed, all test steps must be checked.
Traceability information is given in the Method Sheet of the relevant Elecsys
assay.
Each laboratory should establish corrective measures to be taken if values
fall outside the defined limits.
Precautions and warnings
For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory
reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.
All human material should be considered potentially infectious. All products
derived from human blood are prepared exclusively from the blood of
donors tested individually and shown to be free from HBsAg and antibodies
to HCV and HIV. The testing methods applied were FDA-approved or
cleared in compliance with the European Directive 98/79/EC, AnnexII,
ListA.
However, as no testing method can rule out the potential risk of infection
with absolute certainty, the material should be handled with the same level
of care as a patient specimen. In the event of exposure, the directives of the
responsible health authorities should be followed.1,2
The controls may not be used after the expiration date.
Avoid foam formation in all reagents and sample types (specimens,
calibrators and controls).
Handling
Carefully dissolve the contents of one bottle by adding exactly 3.0mL of
distilled or deionized water and allow to stand closed for 15minutes to
reconstitute. Mix carefully, avoiding foam formation.
Transfer the reconstituted controls into the empty labeled snapcap bottles
supplied or into additional snapcap bottles (ControlSet Vials). Attach the
supplied labels to these additional bottles. Aliquots intended for storage at
-20C should be frozen immediately.
Perform only one control procedure per aliquot.
Please note: Both the vial labels, and the additional labels (if available)
contain 2 different barcodes. The barcode between the yellow markers is
for cobas8000 systems only. If using a cobas8000 system, please turn
2016-04, V 2.0 English
the vial cap 180 into the correct position so the barcode can be read by the
system. Place the vial on the instrument as usual.
PreciControl Lung Cancer also contains SCC antigen. SCC reactive
determinants are shed naturally in skin particles, saliva and other body
fluids and can easily be distributed in dust or aerosols, e.g. as a result of
sneezing. Contamination of the samples, the CalSet Vials or the Elecsys
consumables with SCC may cause falsely elevated SCC results. Gloves
should be used throughout the test procedure when handling reagents,
samples, CalSet Vials etc. A face mask is also recommended.
Storage and stability
Store at 28C.
The lyophilized control serum is stable up to the stated expiration date.
Stability of the reconstituted controls:
either at -20C 28days (freeze only once)
or at 28C 7days
or at 2025C 7hours
Store controls upright in order to prevent the control solution from adhering
to the snapcap.
Materials provided
PreciControl LC, 2barcode cards, control barcode sheet, 2x2 labeled
empty snap-cap bottles, 2x6 bottle labels
Materials required (but not provided)
03142949122, ControlSet Vials, 2x56 empty snapcap bottles
MODULAR ANALYTICSE170 or cobase immunoassay analyzers and
assay reagents
Distilled or deionized water
See the assay Method Sheet and the operators manual for additionally
required materials.
Assay
Treat the reconstituted control serum in the systemcompatible labeled
bottles for analysis in the same way as patient samples.
Read the data into the analyzer.
Ensure the controls are at 2025C prior to measurement.
Run controls daily in parallel with patient samples, once per reagent kit, and
whenever a calibration is performed. The control intervals and limits should
be adapted to each laboratorys individual requirements.
Follow the applicable government regulations and local guidelines for
quality control.
References
1 Occupational Safety and Health Standards: bloodborne pathogens.
(29CFR Part 1910.1030). Fed. Register.
2 Directive 2000/54/EC of the European Parliament and Council of
18September 2000 on the protection of workers from risks related to
exposure to biological agents at work.
For further information, please refer to the appropriate operators manual for
the analyzer concerned, the respective application sheets, the product
information and the Method Sheets of all necessary components (if
available in your country).
A point (period/stop) is always used in this Method Sheet as the decimal
separator to mark the border between the integral and the fractional parts of
a decimal numeral. Separators for thousands are not used.
SCC antigens and ProGRP antigen used in
the Roche PreciControl Lung Cancer are
licensed by Fujirebio Diagnostics, Inc.
Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 152231 standard:
Contents of kit
Analyzers/Instruments on which reagents can be used
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ms_07360070190V2.0

PreciControl Lung Cancer

Reagent
Calibrator
Volume after reconstitution or mixing
GTIN Global Trade Item Number

COBAS, COBASE, ELECSYS and PRECICONTROL are trademarks of Roche.

All other product names and trademarks are the property of their respective owners.
Additions, deletions or changes are indicated by a change bar in the margin.
2016, Roche Diagnostics

Roche Diagnostics GmbH, SandhoferStrasse116, D-68305 Mannheim

www.roche.com

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